Director - Quality Control

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

Organizational Overview:

Analytical Sciences and Quality Control Operations (AQCO) is a center of excellence for analytical stewardship, method lifecycle management (development/validation/transfer and troubleshooting), technology transfer, and analytical troubleshooting.  Our responsibilities include analytical/technical support for Lilly manufacturing sites, external partners, as well as the development, and clinical areas.

Position Overview:

The Director – Analytical Stewardship, AQCO will deliver a diverse portfolio of drug products essential to Lilly as part of the analytical technical stewardship team.  Due to our expanding portfolio, we have an exciting new position available supporting drug product development/commercialization.  The Director will provide technical and scientific expertise within a dynamic and growing team that is supporting commercialization efforts including technical transfers, process validations, and process optimization for a broad product portfolio.  The successful candidate will oversee technical aspects of Drug Product manufacturing, including technical depth of understanding of unit operations, technical transfers, and process validation strategy.  This position requires comprehensive knowledge of the pharmaceutical industry, Good Manufacturing Practices (GMP), regulatory requirements, and the essential role scientists play in making medicine and creating real-world solutions.

Responsibilities:

• Utilize knowledge of development, manufacturing, and regulatory process and expectations to develop the analytical control strategy across products.

• Deepen expertise across technical areas/analytical techniques and be sought out for such expertise.

• Identify and implement key capability/technology gaps and justify/champion investment.

• Interact with other appropriate laboratories (Analytical Development, Quality Control, Third Party) and manufacturing personnel for development, training, transfer, or validation of methodologies or new technologies.

• Lead global/cross functional efforts to drive standardization and/or harmonization.

• Drive development and sustain the product control strategy.

• Drive internal business process improvements across multiple AQCO groups.

• Represent Lilly at external compendial and/or other committees to influence technical practices, globally.

• Develop individuals within and outside AQCO and QC organizations at various sites, coach and mentor colleagues, both peers and associates.

• Mentor new analysts within AQCO, in other laboratories, or at other QC Labs/sites.

• Influence development laboratories to utilize new technologies for product/process monitoring and control. Work with product development teams to improve quality of deliverables for new chemical entities or formulation line extensions.

• Work closely with Development and Global Regulatory teams to author/review regulatory submission documents and subsequently respond to Information Requests/Regulatory Questions.

• Remain current on external pharmaceutical manufacturing trends and innovations.  Leverage these to improve strategies and applications for developing and controlling manufacturing processes. 

• Prepare, review, and approve study designs, protocols, technical reports, and other related technical documentation.  As a reviewer of technical reports, provide input on the experimental findings and conclusions. 

Basic Requirements:

• MS in a scientific discipline of Biochemistry, Chemistry, Chemical Engineering or related fields.

• 10+ years supporting complex analytical testing

Additional Skills/Preferences:

• Demonstrated experience and proficiency with pharmaceutical manufacturing and working knowledge of regulatory expectations.

• Proven experience leading post launch technical agendas and delivering projects that have driven substantial step changes in manufacturing.

• Prior technical leadership experience.

• Prior experience at commercial manufacturing site.

• Demonstrated technical writing ability.

• Demonstrated strong problem-solving skills.

• Strong verbal and written communication skills.

• Demonstrated strong interpersonal skills, with a proven ability to influence diverse groups and manage relationships.

• Demonstrated leadership skills (decision making, prioritization, mentoring, conflict resolution).

• Demonstrated flexibility when faced with changing priorities.

• Strong attention to detail.

Additional Information:

• Primary location is North Carolina, supporting internal and external manufacturing sites.

• Travel: approximately 5-10%

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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